Quality Engineer

Job Listing No: 9740000

Quality Engineer

i-Pharm Consulting – Australia – JOB TITLE Senior Quality Engineer –– Victoria based JOB SUMMARY A Quality Engineer is required for a small but growing medical devices company building their global operation from Melbourne. The company has recently had a large capital injection globally providing an exciting phase in their growth. There will be manufacturing and production on site. ROLE/DESCRIPTION Broad based Quality Engineering role supporting management Maintain Quality Management system in line with ISO13485, GMP, 21CFR820 and other standards relevant to the design, development, manufacture and distribution of a product. Document Control Configuration Management Provide oversight on CA/PA related activates REQUIREMENTS Life sciences degree (pharmacy preferred) Extensive experience in Australian Regulatory Affairs (and New Zealand ideally) Experience with TGA, Medsafe and ideally the FDA ISO 13485 knowledge People management would be a bonus Electronic QMS in a medical device setting … – Permanent – Full-time

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